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FDA 510(k), K150790, REDAPT Porous Acetabular Shell and Cemented Liner
FDA 510(k), K150790, REDAPT Porous Acetabular Shell and Cemented Liner
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510(K) Number: K150790
Device Name: REDAPT Porous Acetabular Shell and Cemented Liner
Manufacturer: JEFF SPRAGUE
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: LPH
Classification Product Code: 03/25/2015
Date Received: 11/16/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: REDAPT Porous Acetabular Shell and Cemented Liner
Manufacturer: JEFF SPRAGUE
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: LPH
Classification Product Code: 03/25/2015
Date Received: 11/16/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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